InfertilitySTARNCT02268786
Single Embryo TrAnsfeR of Euploid Embryo
A study testing Preimplantation Genetic Screening by NGS in people with Infertility and Aneuploidy, run by Illumina, Inc. at 38 sites in 4 countries.
Trial summary
The purpose of the current study is to evaluate the effect of preimplantation genetic screening (PGS) by next generation sequencing (NGS) compared to standard morphological assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Infertility, Aneuploidy
- What is being tested?
- Preimplantation Genetic Screening by NGS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 661 participants
- Where
- 38 sitesin 4 countries
- Study dates
- Sep 2014to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient undergoing IVF
- At least 2 blastocysts suitable for biopsy on day 5 or 6 of embryo development
Who cannot join
- History of more than two prior implantation failure following IVF
- History of more than one miscarriage of viable pregnancy
- One or both partners known to be carrier(s) of a chromosomal abnormality
- Known genetic carrier couple and/or one or both partners carrier of a known autosomal dominant disorder
- Any other non-study related preimplantation genetic testing
- Use of donor oocytes
Show all 11Show fewer
- Use of gestational carrier (surrogate or donor egg recipient).
- Severe oligospermia (<1,000,000 sperm/ml); Surgical Sperm Retrieval for reasons other than post-vasectomy and CAVD
- Low ovarian reserve with (FSH) >10 IU/L on day 2-4 of a prior menstrual cycle and/or (AMH) <7 pmol/L (or <1 ng/ml)
- Gender selection cycles
- Concurrent participation in another clinical trial
Trial locations and contacts
38 sites in 4 countries.
38 sites in 4 countries
United States28 sites
Georgia Reproductive Specialists
Atlanta, Georgia, 30342
Texas Fertility Center
Austin, Texas, 78731
IVF Michigan
Bloomfield Hills, Michigan, 48304
Main Line Fertility
Bryn Mawr, Pennsylvania, 19010
Dallas Fertility Center
Dallas, Texas, 75231
Reproductive Science Center of New Jersey
Eatontown, New Jersey, 07724
HRC Fertility
Encino, California, 91436
Dallas IVF
Frisco, Texas, 75034
Fertility Center of Illinois, Highland Park
Highland Park, Illinois, 60035
Fertility Institute of Hawaii
Honolulu, Hawaii, 96814
Houston Fertility Institute
Houston, Texas, 77063
Acacio Fertility Clinic
Laguna Niguel, California, 92677
IVF New England
Lexington, Massachusetts, 02421
Reprogenetics (USA) - Genetics Laboratory
Livingston, New Jersey, 07039
IRMS at St. Barnabas
Livingston, New Jersey, 07078
Colorado Center for Reproductive Medicine (CCRM)
Lonetree, Colorado, 80125
The Advanced IVF Institute
Naperville, Illinois, 60540
Reproductive Associates of Delaware
Newark, Delaware, 19713
CRM Orlando
Orlando, Florida, 32804
HRC Fertility Pasadena
Pasadena, California, 91105
Utah Fertility Center
Pleasant Grove, Utah, 84062
Genesis Genetics (USA) - Genetics Laboratory
Plymouth, Michigan
Fertility Specialists Medical Group
San Diego, California, 92123
Reproductive Science Center of San Francisco Bay Area
San Ramon, California, 94583
Reproductive Care Center
Sandy City, Utah, 84092
Seattle Reproductive Medicine
Seattle, Washington, 98109
Fertility Treatment Center
Tempe, Arizona, 85284
CORM Houston
Webster, Texas, 77598
United Kingdom6 sites
Boston Place Clinic
London, Greater London, NW1 6ER
Care Fertility Group London
London, Greater London, NW8 7JL
Genesis Genetics (UK) - Genetics Laboratory
London
Care Fertility Group Manchester
Manchester, Greater Manchester, M14 SHQ
Oxford Fertility Unit
Oxford, Oxfordshire, OX42HW
Reprogenetics (UK) - Genetics Laboratory
Oxford
Canada3 sites
Reproductive Care Center
Mississauga, Ontario, L5N 5S3
TRIO Fertility Treatment Practice
Toronto, Ontario, M5G 2K4
Olive Fertility Centre
Vancouver, British Columbia, V5Z 3X7
About this study
Official title: Prospective, Multi-center, Randomized Controlled Trial Comparing Pregnancy Outcomes Following Selection and Single Embryo Transfer (SET) Based on Preimplantation Genetic Screening (PGS) by Next Generation Sequencing (NGS) Versus Standard Morphological Assessment
The purpose of the current study is to evaluate the effect of preimplantation genetic screening (PGS) by next generation sequencing (NGS) compared to standard morphological assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). All embryos will be vitrified and a single embryo transfer (SET) will be performed with either screened or unscreened embryos depending on randomization.
- Conditions
- Infertility, Aneuploidy
- Being tested
- Preimplantation Genetic Screening by NGS
- Keywords
- Preimplantation Genetic Screening, Blastocyst, Vitrification, In vitro fertilization, non-invasive prenatal testing, next generation sequencing
- Medical subject headings
- Infertility, Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preimplantation Genetic Screening by NGSOther
Also called Veriseq PGS
The VeriSeq PGS takes advantage of next-generation sequencing (NGS) technology to provide comprehensive, accurate screening of all 24 chromosomes for selection of euploid embryos.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Intent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts Receives: Other: Preimplantation Genetic Screening by NGS |
| Group B | No intervention | Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing Pregnancy
Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation
Measured: Gestational Age of 20 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startSep 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- Illumina, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Reprogenetics, Genesis Genetics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268786
- Sponsor's protocol ID
- RGH-001
- Acronym
- STAR
- Status last verified
- May 2020
- First submitted
- 15 Oct 2014
- Last updated
- 13 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Handyside AH. 24-chromosome copy number analysis: a comparison of available technologies. Fertil Steril. 2013 Sep;100(3):595-602. doi: 10.1016/j.fertnstert.2013.07.1965.
PubMed 23993662Schoolcraft WB, Katz-Jaffe MG. Comprehensive chromosome screening of trophectoderm with vitrification facilitates elective single-embryo transfer for infertile women with advanced maternal age. Fertil Steril. 2013 Sep;100(3):615-9. doi: 10.1016/j.fertnstert.2013.07.1972.
PubMed 23993664Yang Z, Liu J, Collins GS, Salem SA, Liu X, Lyle SS, Peck AC, Sills ES, Salem RD. Selection of single blastocysts for fresh transfer via standard morphology assessment alone and with array CGH for good prognosis IVF patients: results from a randomized pilot study. Mol Cytogenet. 2012 May 2;5(1):24. doi: 10.1186/1755-8166-5-24.
PubMed 22551456Fiorentino F, Biricik A, Bono S, Spizzichino L, Cotroneo E, Cottone G, Kokocinski F, Michel CE. Development and validation of a next-generation sequencing-based protocol for 24-chromosome aneuploidy screening of embryos. Fertil Steril. 2014 May;101(5):1375-82. doi: 10.1016/j.fertnstert.2014.01.051. Epub 2014 Mar 6.
PubMed 24613537Bianchi DW, Parker RL, Wentworth J, Madankumar R, Saffer C, Das AF, Craig JA, Chudova DI, Devers PL, Jones KW, Oliver K, Rava RP, Sehnert AJ; CARE Study Group. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014 Feb 27;370(9):799-808. doi: 10.1056/NEJMoa1311037.
PubMed 24571752Munne S, Kaplan B, Frattarelli JL, Child T, Nakhuda G, Shamma FN, Silverberg K, Kalista T, Handyside AH, Katz-Jaffe M, Wells D, Gordon T, Stock-Myer S, Willman S; STAR Study Group. Preimplantation genetic testing for aneuploidy versus morphology as selection criteria for single frozen-thawed embryo transfer in good-prognosis patients: a multicenter randomized clinical trial. Fertil Steril. 2019 Dec;112(6):1071-1079.e7. doi: 10.1016/j.fertnstert.2019.07.1346. Epub 2019 Sep 21.
PubMed 31551155Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.
PubMed 32898291
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Randomized Controlled Trial Comparing Pregnancy Outcomes Following Selection and Single Embryo Transfer (SET) Based on Preimplantation Genetic Screening (PGS) by Next Generation Sequencing (NGS) Versus Standard Morphological Assessment
- ClinicalTrials.gov ID
- NCT02268786
- Acronym / sponsor ID
- STAR / RGH-001
- Conditions
- Infertility, Aneuploidy
- Keywords
- Preimplantation Genetic Screening, Blastocyst, Vitrification, In vitro fertilization, non-invasive prenatal testing, next generation sequencing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- Illumina, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Reprogenetics, Genesis Genetics
- Study start
- Sep 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Posted 4 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the current study is to evaluate the effect of preimplantation genetic screening (PGS) by next generation sequencing (NGS) compared to standard morphological assessment of embryos on pregnancy rates through a randomized controlled trial (RCT). All embryos will be vitrified and a single embryo transfer (SET) will be performed with either screened or unscreened embryos depending on randomization.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Preimplantation Genetic Screening by NGSIntent to transfer single euploid embryo based on NGS testing (VeriSeq™ PGS) of biopsied blastocysts |
| Group B | No intervention | –Intent to transfer single embryo based on morphological assessment according to the Gardner scoring system (no PGS) |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient undergoing IVF
- At least 2 blastocysts suitable for biopsy on day 5 or 6 of embryo development
Key exclusion criteria (11 listed)
- History of more than two prior implantation failure following IVF
- History of more than one miscarriage of viable pregnancy
- One or both partners known to be carrier(s) of a chromosomal abnormality
- Known genetic carrier couple and/or one or both partners carrier of a known autosomal dominant disorder
- Any other non-study related preimplantation genetic testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preimplantation Genetic Screening by NGSAlso: Veriseq PGSThe VeriSeq PGS takes advantage of next-generation sequencing (NGS) technology to provide comprehensive, accurate screening of all 24 chromosomes for selection of euploid embryos. | Other | Group A |
Primary outcome
Ongoing Pregnancy
Time frame: Gestational Age of 20 Weeks
Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23993662Handyside AH. 24-chromosome copy number analysis: a comparison of available technologies. Fertil Steril. 2013 Sep;100(3):595-602. doi: 10.1016/j.fertnstert.2013.07.1965.
- Results publication: PubMed 23993664Schoolcraft WB, Katz-Jaffe MG. Comprehensive chromosome screening of trophectoderm with vitrification facilitates elective single-embryo transfer for infertile women with advanced maternal age. Fertil Steril. 2013 Sep;100(3):615-9. doi: 10.1016/j.fertnstert.2013.07.1972.
- Results publication: PubMed 22551456Yang Z, Liu J, Collins GS, Salem SA, Liu X, Lyle SS, Peck AC, Sills ES, Salem RD. Selection of single blastocysts for fresh transfer via standard morphology assessment alone and with array CGH for good prognosis IVF patients: results from a randomized pilot study. Mol Cytogenet. 2012 May 2;5(1):24. doi: 10.1186/1755-8166-5-24.
- Results publication: PubMed 24613537Fiorentino F, Biricik A, Bono S, Spizzichino L, Cotroneo E, Cottone G, Kokocinski F, Michel CE. Development and validation of a next-generation sequencing-based protocol for 24-chromosome aneuploidy screening of embryos. Fertil Steril. 2014 May;101(5):1375-82. doi: 10.1016/j.fertnstert.2014.01.051. Epub 2014 Mar 6.
- Results publication: PubMed 24571752Bianchi DW, Parker RL, Wentworth J, Madankumar R, Saffer C, Das AF, Craig JA, Chudova DI, Devers PL, Jones KW, Oliver K, Rava RP, Sehnert AJ; CARE Study Group. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014 Feb 27;370(9):799-808. doi: 10.1056/NEJMoa1311037.
- Results publication: PubMed 31551155Munne S, Kaplan B, Frattarelli JL, Child T, Nakhuda G, Shamma FN, Silverberg K, Kalista T, Handyside AH, Katz-Jaffe M, Wells D, Gordon T, Stock-Myer S, Willman S; STAR Study Group. Preimplantation genetic testing for aneuploidy versus morphology as selection criteria for single frozen-thawed embryo transfer in good-prognosis patients: a multicenter randomized clinical trial. Fertil Steril. 2019 Dec;112(6):1071-1079.e7. doi: 10.1016/j.fertnstert.2019.07.1346. Epub 2019 Sep 21.
- Derived from this study: PubMed 32898291Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preimplantation Genetic Screening by NGS in people with Infertility and Aneuploidy, run by Illumina, Inc. at 38 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, United Kingdom, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing Pregnancy (time frame: Gestational Age of 20 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02268786, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.